Symfony Plus has Received FDA Approval.
Posted , 7 users are following.
this is a symfony with a near add or perhaps a trifocal. Shannon Wong just mentioned it on Youtube and it is also listed on FDA approval as of 5/1.
this lens was also mentioned to me by dr. safran from new jersey. but that was a couple of months before the panoptix was approved.
1 like, 21 replies
charles94562 soks
Posted
Hi RonAKA. What was the title of the Shannon Wong video? Googling the IOL I find clinical trial info that sites a 2021 completion date. Can you point to the source of the FDA approval? Thanks.
soks charles94562
Posted
RonAKA is a different person.
for fda approval you can search for
p980040s109
charles94562 soks
Posted
Sorry soks, my eyesight truly is bad!
soks charles94562
Posted
ha ha. thats funny. sad truth for us.
soks
Posted
DeviceTECNIS Symfony PLUS Extended Range Of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range Of
Generic NameExtended Depth Of Focus Intraocular Lens
Regulation Number886.3600
Applicant
Johnson & Johnson Surgical Vision, Inc.
1700 E. St. Andrew Place
Santa Ana, CA 92705
PMA NumberP980040
Supplement NumberS109
Date Received11/06/2019
Decision Date05/01/2020
Product Code POE
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/Components/Specifications/Material
Expedited Review Granted?No
Combination Product No
Approval Order Statement
modification of the optics to elongate the depth of focus further than the optical parent lens, the TECNIS Symfony
john56935 soks
Posted
Thanks for the tip, Soks! Wonder how much greater DOF this has over older Symfony and if they have toned down the nighttime issues. Seems like this would be the more logical choice over Panoptix if you already have a Symfony. Wonder how this got approved before Eyhance too but maybe this is a better option now.
Sue.An2 soks
Posted
interesting!
janus381 soks
Edited
Not much buzz on Symfony Plus. It's not surprising it got FDA approval quickly as it is just a modification of an existing FDA approved lens. But at the same time, I guess the question is how much of an improvement does it really provide, or is this J&J protecting US market share against PanOptix until J&J gets their tri-focal approved in the US.
One article... search for "In the Pipeline CRSToday" for article from April this year.
Apparently, the Symfony Plus now adds a "violet light blocker".
The doctor writes this about Symfony Plus: "Time will tell whether Tecnis Symfony Plus achieves the same distance acuity benchmark and thus replaces Tecnis Symfony in our practice or whether the two end up being complementary, either in a personalized mix-and-match scenario or through patient selection."
The article also highlights (earlier in the story) two IOLs in development that sound like they have promise.
soks janus381
Posted
that's a great article. vivity appears to be very promising. no rings and vision upto 66cm is so tempting.
it makes 2 references to near improvement: a) 1 line improvement and b) large improvement.
would be nice to see the defocus curve.
what is the difference between blue light filter and UV filter.? tecnic optiblue is the blue light that makes it yellow.
janus381 soks
Posted
UV filter is standard in every IOL now.
Some manufacturers (including Alcon in the PanOptix lens I have)have added a blue filter as they believe based on animal studies blue filter helps protect the retina, and may help prevent macular degeneration. But there is a debate on the pros and cons.
Seems like violet light filter (which Symfony Plus has) is the latest develop on the blue filter trend -- providing some retinal protection.
soks janus381
Posted
does that filter make it yellow like the synergy? yellow tecnis iols are suffixed with a V. ZHR00V would be yellow symfony plus.
janus381 soks
Posted
In my long post about my PanOptix experience from 9 months ago (it's on page 2 now), I did not notice any major difference in color in the week between my Right eye (which had the more severe cataract) and my left eye surgery.
My comment was (copying from my old post):
The PanOptix lens has both a UV filter (this is standard) and a blue light filter (several manufacturers have added this as they think it may help reduce risk of macular disease, while some other manufacturers don’t believe blue filter is beneficial). I compared the colors I see with my new Right eye (which has the IOL) with my left eye (still natural lens but with cataracts). I don’t notice any perceptible difference in color, except when looking at my wood deck is pressure treated wood with a semi-transparent still. With my left eye (natural lens with cataract), the wood has a more yellowish hue compared to my Right eye (IOL with blue filter), but difference is not major.
Now they say cataract will make colors more yellowish, so the difference could be due to the cataract in my natural eye. But other than looking at pressure treated wood, I did not notice any difference in color. I've also read articles about experience of visual artists with blue filter IOL, and I don't recall anyone commenting on difference in color perception.
From sounds of it, violet filter should have even less impact on colors than blue filter.
I believe whatever filter manufacturers use, they are not getting too much into the visible light spectrum.
soks
Posted
vivity also got fda approved in february so should be available soon in US
i think it may not have that good intermediate as only 37% have 20/25 or better for intermediate vision per FDA website.
soks
Posted
charles94562 soks
Posted
Hi soks. What is the source of the image? I'm finding very little on the Google about Plus.
soks charles94562
Posted
google image search. there is an article by Ashley McEvoy for Leading in Eye Health